Effect of Raltegravir in Patients With Acute Tropical Spastic Paraparesis - Human T-Lymphotropic Virus 1 Infection
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|ClinicalTrials.gov Identifier: NCT02655471|
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|HTLV-I Infections Tropical Spastic Paraparesis||Drug: "Raltegravir" and "Zidovudine"||Early Phase 1|
The study will the investigators develop in The Tropical Medicine Institute Alexander von Humboldt that is a referral center in Peru for diseases associated to Human T-Lymphotropic Virus 1 Infection (HTLV-1). The Institute has a cohort of around 600 patients currently being followed up and around 20 to 25 new patients are admitted every year with this disease.
This is a pilot study of intervention in a group of patients with tropical spastic paraparesis/ myelopathy to evaluate virologic and clinical response of raltegravir plus zidovudine in this group of patients on the follow-up of 48 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Raltegravir in Patients With Myelopathy/Tropical Spastic Paraparesis Associated With Infection by Human T-Lymphotropic Virus 1 (HTLV-1). Pilot Study|
|Actual Study Start Date :||July 1, 2017|
|Actual Primary Completion Date :||March 15, 2019|
|Actual Study Completion Date :||March 15, 2019|
Experimental: HTLV-1 plus Tropical Spastic paraparesis
Patients with recent onset of Tropical Spastic paraparesis due HTLV-1 will receive combination of "Raltegravir" and "Zidovudine" during 48 weeks
Drug: "Raltegravir" and "Zidovudine"
Through measure of pro-viral load and clinical score, we evaluate about safety and efficacy of combination of Raltegravir 400 mg BID and zidovudine 300 mg BID in patients with recent onset of Tropical Spastic paraparesis due HTLV-1 during 48 weeks
- Measure of proviral load [ Time Frame: 48 weeks ]Evaluate the effect of raltegravir on proviral load , measured as copies/1000 PBMC, in patients with myelopathy of recent onset associated to HTLV-1 at 48 weeks.
- Measure of Disability Scale [ Time Frame: 48 weeks ]Evaluate the effect of raltegravir on Kurtzke Expanded Disability Status Scale in patients with myelopathy of recent onset associated to HTLV-1 at 48 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655471
|Instituto de Medicina Tropical Alexander von Humboldt|
|Lima, Peru, 01|
|Principal Investigator:||Eduardo Gotuzzo, MD||Instituto de Medicina Tropical Alexander von Humboldt|
|Principal Investigator:||Fernando Mejía, MD||Instituto de Medicina Tropical Alexander von Humboldt|